How the Roadsaver stent changed my practice in CAS

Transcription

1 Room 2- Main Arena 2: Tuesday, Jan 22, :00-15:10 How the Roadsaver stent changed my practice in CAS Roadsaver CGUARD GORE S.Müller-Hülsbeck, MD, EBIR, FCIRSE, FICA, FSIR ACADEMIC HOSPITALS Flensburg of Kiel University Faculty of Medicine Ev.-Luth. Diakonissenanstalt zu Flensburg Knuthstraße 1, FLENSBURG Dept. of Diagnostic and Interventional Radiology / Neuroradiology 1

2 Disclosure I have the following potential conflicts of interest to report: Consulting Boston Scientific, Terumo, Eurocor Tech 2

3 Unmet Need In The CAS Market Sustained Embolic Protection No stent or EPS protects against late embolization Eur J Vasc Endovasc Surg Vol 33, Feb

4 Closed Cell Stents In CAS Hopf-Jensen S, Marques L, Preiß M, Müller-Hülsbeck S. Int J Angiol 2014;23(4):

5 Closed Cell Stents In CAS - Clinical outcome and complications 101 pts., symptomatic Complications during procedure at 30 days follow up Death Major stroke Minor stroke Hyperperfusionsyndrom TIA myocardical infarction stroke rate 2.9% Overall death & stroke stroke rate 30 days Hopf-Jensen S, Marques L, Preiß M, Müller-Hülsbeck S. Int J Angiol 2014;23(4):

6 Cell Size Comparison Micromesh ( µm) Roadsaver Stent A Stent B Stent C Stent D Stent E 6

7 Stent Features & Benefits Dual Layer Braided Stent with Micro-mesh Technology Inner layer Micro-mesh with very small cell size ( µm) limits plaque prolapse and embolic release Outer layer Conformability: Braided Nitinol design allows for in-vivo stent tapering and conformability to ICA- CCA segments Flexibility: Closed cell stent with the flexibility of open cell stent, resulting in excellent vessel wall apposition in tortuous anatomy 7

8 Dual Layer Stent Designs CGUARD Closed cell stent TERUMO GORE 8

9 Dual Layer Stent Designs CGUARD TERUMO double layer micromesh nitinol scaffold, up to 50% deployment full re-sheathable and repositionable; pore size 375µm 6 pts -Procedure success 100% -Procedural complications 0% Closed cell stent Open cell stent -30-day MAE cardiac or cerebrovascular 0% -6-months MAE cardiac or cerebrovascular 0% Hopf-Jensen S, Marques L, Preiß M, Müller-Hülsbeck S. Initial clinical experience with the micromesh Roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. J Endovasc Ther Apr;22(2): GORE 12 pts -no ischemia Wissgott C, Schmidt W, Brandt C, Behrens P, Andresen R. Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent. J Endovasc Ther Aug;22(4):

10 Dual Layer Stent Designs CGUARD TERUMO GORE double layer micromesh nitinol scaffold, up to 50% deployment full re-sheathable and repositionable; pore size 375µm 100 pts, multi-center, prospective -Procedure success 100% -Procedural complications 0% Closed cell stent Open cell stent -30-day MAE cardiac or cerebrovascular 2.1% Bosiers M, Deloose K, Torsello G, Scheinert D, Maene L, Peeters P, Müller-Hülsbeck S, Sievert H, Langhoff R, Bosiers M, Setacci C. The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery. EuroIntervention Aug 5;12(5):e pts, single-center, prospective -30-day MAE cardiac or cerebrovascular 0% -30-day DWI MRI lesions 0% Ruffino MA, Faletti R, Bergamasco L, Fonio P, Righi D. Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study. Cardiovasc Intervent Radiol Nov;39(11): Epub 2016 Aug

11 Smaller Pore Size More Material: Enhanced Thrombogenicity? CGUARD *165µ Closed cell stent Open cell stent Roadsaver GORE * Average in lesion at expanded state 11

12 Dual Layer Stent Designs: Early Reports CGUARD Roadsaver CARENET: 30 pts, EPDs were used in all procedures -Procedure success 100% -Procedural complications 0% -30-day MAE cardiac or cerebrovascular 0% Schofer J, Musiałek P, Bijuklic K, Kolvenbach R, Trystula M, Siudak Z, Sievert H. A Prospective, Multicenter Study of -New a Novel Mesh-Covered ipsilateral Carotid Stent: ischemic The CGuard CARENET lesions Trial (Carotid at Embolic 48 Protection h Using 37.0% MicroNet). JACC Cardiovasc Interv Aug 17;8(9): Clear-Road: 100 pts, multi-center, prospective -Procedure success 100% -Procedural complications 0% Bosiers M, Deloose K, Torsello G, Scheinert D, Maene L, Peeters P, Müller-Hülsbeck S, Sievert H, Langhoff R, Bosiers -30-day M, Setacci C. MAE The CLEAR-ROAD cardiac study: evaluation or cerebrovascular of a new dual layer micromesh stent system 2.1% for the carotid artery. EuroIntervention Aug 5;12(5):e671-6 GORE Scaffold-Trial: 312 pts, multi-center, prospective -Procedure success 100% -Procedural complications 0% Presented at Veith day MAE cardiac or cerebrovascular 1.1% 12

13 Roadsaver Dual Layer CAS: The Flensburg Experience CGUARD Flensburg Dual-Layer Carotid Stents Experience ongoing Total total stroke rate days n=11 n=30 n=30 n=23 Roadsaver n=8 CGuard n=28 Roadsaver n=9 CGuard n=122 Roadsaver n=17 CGuard 2/ % ISR after 12 months based on US (asymptomatic) 5/ % Symptomatic/ asymptomatic 11/0 26/4 23/7 17/14 25/12 102/37 1.4%/0% 1.4%/2.2% symptomatic (acute stroke) Tandem lesion n=3 n=17 n=11 n=8 Roadsaver n=1 CGuard n=10 Roadsaver n=3 CGuard n=53 No acute occlusion!! 1/53 asymptomatic occlusion 1.9% 13

14 How do I treat today patients with Roadsaver Emergency treatment: Bridging 0.9mg/kg BW r-tpa antiplatelet medication Peri-procedural 5000 units Heparine (ACT 250s-300s) 500mg ASA i.v. Roadsaver 300mg Clopidogrel after control (conebeam-)ct, day 1 Post-procedural 75mg Clopidogrel for 6 months 100mg ASA life-long 14

15 How do I treat today patients with Roadsaver Elective treatment: antiplatelet medication Pre-procedural Roadsaver 300mg Clopidogrel and 100mg ASA (5 days before or loading dose 300mg Clopidogrel) Peri-procedural 5000 units Heparine (ACT 250s-300s) Post-procedural 75mg Clopidogrel for 6 months 100mg ASA life-long 15

16 How do I treat today patients with Roadsaver Stent sizing 7mm or 8mm diameter 18mm to 25mm lenght Roadsaver Stent-deployment Continous Stent post-dilatation 5mm in all cases!! 16

17 Dual-Layer Carotid Stents: proven concept of safety Hopf-J Jensen S, Marques L, Preiß M, Müller-Hülsbeck S. Initial clinical experience with the micromesh Roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. J Endovasc Ther Apr;22(2): Roadsaver n=7 Nerla R, Castriota F, Micari A, Sbarzaglia P, Secco GG, Ruffino MA, de Donato G, Setacci C, Cremonesi A. Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach. EuroIntervention Aug 5;12(5):e n=150 Ruffino MA, Faletti R, Bergamasco L, Fonio P, Righi D. Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Singlen=23 Centre Study. Cardiovasc Intervent Radiol Nov;39(11): Machnik R, Paluszek P, Tekieli Ł, Dzierwa K, Maciejewski D, Trystuła M, Brzychczy A, Banaszkiewicz K, Musiał R, Pieniążek P. Mesh-covered (Roadsaver) stent as a new treatment modality for symptomatic n=41 or high-risk carotid stenosis. Postepy Kardiol Interwencyjnej. 2017;13(2): Bosiers M, Deloose K, Torsello G, Scheinert D, Maene L, Peeters P, Müller-Hülsbeck S, Sievert H, Langhoff R, Bosiers M, Setacci C. The CLEAR-ROAD study: evaluation of a new dual layer micromesh n=100 stent system for the carotid artery. EuroIntervention Aug 5;12(5):e671-6 Preparation + ongoing antiplatelet medication 17

18 Catheter Cardiovasc Interv Dec 14. Roadsaver subgroup demonstrated very low rates of post procedural AEs at 30-day. 299 patients Death and Stroke Rate 0.02% 18

19 ROADSAVER Study Prospective, single-arm, multi-center, observational study STUDY FLOW Eligibility Assesment Primary Outcome measure: The rates of Major Adverse Events (MAEs) defined as the cumulative incidence of any death or stroke up to 30 days after the index procedure Baseline (succesfull stent implantation) Yes 1 Month FU (hospital) No Follow-up until discharge No Study Organization: Independent Clinical Events Committee (CEC) Steering Committee (SC) Sponsored by Terumo Europe European Medical & Clinical Division (EMCD) 12 Months FU (hospital/call) 19

20 ROADSAVER Study Overview 8 active countries 26 sites activated 23 sites to be activated 226/2000 patients enrolled 20

21 Delivery System Features & Benefits Fully repositionable with up to 50% deployment, improving stent placement accuracy Delivery catheter with flexible distal design to enhance trackability in highly challenging anatomy 1 Low profile 5 Fr sheath compatible system enhances the crossability for stenting 2 1 Compared to other other stent delivery systems. Roadsaver the paradigm shift in carotid artery treatment. Giovanni Torsello, Münster, Germany. Presentation on LINC, 26 January 2016, Leipzig, Germany 2 Compared to other stent delivery systems. Roadsaver innovative solutions for CAS. Stefan Müller- Hülsbeck, Flensburg, Germany. Presentation on LINC, 24 January 2017, Leipzig, Germany 21

22 CGUARD 7x30 22

23 Crossing Profile RoadSaver 7x18 CGUARD 7x30 6F D=2mm 3.14mm 2 RoadSaver 7x18 5F D=1.67mm 2.19mm 2 30% difference! 23

24 Unmatched clinical needs? ICA ECA The ECA with Roadsaver remains 6months! 24

25 Switching from single to dual layer stent? 25

26 Switching from single to dual layer stent? 26

27 Anything to add? We know that with CAS, there are two critical ways to avoid stroke: patient selection an operator experience Mark Wholey: J Endovasc Ther 2007; 14:

28 Room 2- Main Arena 2: Tuesday, Jan 22, :00-15:10 How the Roadsaver stent changed my practice in CAS Roadsaver CGUARD GORE S.Müller-Hülsbeck, MD, EBIR, FCIRSE, FICA, FSIR ACADEMIC HOSPITALS Flensburg of Kiel University Faculty of Medicine Ev.-Luth. Diakonissenanstalt zu Flensburg Knuthstraße 1, FLENSBURG Dept. of Diagnostic and Interventional Radiology / Neuroradiology 28